This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives. STORAGE NAME: h0117c.HHS DATE: 3/17/2023 HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: HB 117 Genetic Counselors Using Telehealth SPONSOR(S): Silvers TIED BILLS: IDEN./SIM. BILLS: REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Healthcare Regulation Subcommittee 18 Y, 0 N Osborne McElroy 2) Health & Human Services Committee 20 Y, 0 N Osborne Calamas SUMMARY ANALYSIS Telehealth is the remote provision of health care services through the use of technology. Telehealth is not a type of health care service, but rather is a mechanism for the delivery of health care services. Section 456.74, F.S., enacted in 2019, regulates the use of telehealth by Florida and out-of-state healthcare providers. The law specifically lists the health care practitioner types and out-of-state health care providers authorized to provide health care services through telehealth. The list includes all health care practitioner types regulated by the Department of Health (DOH) in 2019. Genetic counselors collect personal and family history and use such information to determine how likely it is that an individual or their family member has a genetic condition. Based on such information, a genetic counselor assists an individual in determining if a genetic test is suitable. Genetic test results can help diagnose, confirm, or indicate increased risk for developing a particular condition which genetic counseling can help explain the results and available treatment options. In 2021, genetic counseling became a licensed health care profession regulated by the Department of Health with the enactment of part III of chapter 483, F.S. However, genetic counselors were not added to s. 456.74, F.S. list of health care practitioner authorized to provide services through telehealth. Genetic counselors are currently the only health care practitioner type that cannot provide services through telehealth. HB 117 authorizes genetic counselors licensed or registered in Florida to provide services to patients through telehealth. The bill has an indeterminate, insignificant negative fiscal impact on DOH which can be absorbed within current resources. The bill provides an effective date of July 1, 2023. STORAGE NAME: h0117c.HHS PAGE: 2 DATE: 3/17/2023 FULL ANALYSIS I. SUBSTANTIVE ANALYSIS A. EFFECT OF PROPOSED CHANGES: Present Situation Telehealth Telehealth is not a type of health care service, but rather is a mechanism for the delivery of health care services. Health care professionals use telehealth as a platform to provide traditional health care services in a non-traditional manner. These services include, among others, preventative medicine and the treatment of chronic conditions. 1 Section 456.74, F.S., enacted in 2019, regulates the use of telehealth by Florida and out-of-state healthcare providers. Current law broadly defines telehealth as the use of synchronous or asynchronous telecommunications technology by a telehealth provider to provide health care services, including, but not limited to: 2 Assessment, diagnosis, consultation, treatment, and monitoring of a patient; Transfer of medical data; Patient and professional health-related education; Public health services; and Health administration. Current law sets the standard of care for telehealth providers at the same level as the standard of care for health care practitioners or health care providers providing in-person health care services to patients in this state. This ensures that a patient receives the same standard of care irrespective of the modality used by the health care professional to deliver the services. A patient receiving telehealth services may be in any location at the time services are rendered and a telehealth provider may be in any location when providing telehealth services to a patient. 3 Health care services may be provided via telehealth by a Florida-licensed health care practitioner, a practitioner licensed under a multistate health care licensure compact of which Florida is a member, 4 or a registered out-of-state-health care provider. 5 Out-of-state health care providers may provide services to patients in Florida using telehealth upon registering with DOH as an out-of-state telehealth provider. 6 Out-of-state providers must provide services within their applicable scope of practice as established by Florida law or rule. 7 The out of-state telehealth provider registration does not expire; however, registered providers must comply with all registration requirements until they request to nullify their registration. 8 In order to register as an out-of-state telehealth provider, one must: 9 Submit a completed application in the format prescribed by DOH; Maintain an active and unencumbered license, which is substantially similar to a license issued to a Florida practitioner in the same profession, in a U.S. state or jurisdiction; 1 U.S. Department of Health and Human Services, Report to Congress: E-Health and Telemedicine (August 12, 2016), available at https://aspe.hhs.gov/system/files/pdf/206751/TelemedicineE-HealthReport.pdf (last visited January 23, 2023). 2 S. 456.47(1)(a), F.S. 3 S. 456.47(2), F.S. 4 Florida is a member of the Nurse Licensure Compact. See s. 464.0095, F.S. 5 S. 456.47(4), F.S. 6 Id. 7 Id. 8 Florida Department of Health. Division of Medical Quality Assurance. Florida Telehealth: Frequently Asked Questions. Available at https://flhealthsource.gov/telehealth/faqs/ (last visited February 7, 2023). 9 S. 456.47(4), F.S. STORAGE NAME: h0117c.HHS PAGE: 3 DATE: 3/17/2023 Not have been the subject of disciplinary action relating to his or her license during the five-year period preceding the submission of the application; 10 Designate a duly appointed registered agent for the service of process in Florida; and Maintain professional liability coverage or financial responsibility for telehealth services provided to patients in Florida in an amount equal to or greater than that required for Florida-licensed practitioners. 11 Current law authorizes the following licensed health care practitioners to provide services through telehealth: 12 This list includes all health care practitioner types regulated by DOH in 2019 when the law authorizing telehealth in Florida was passed. Genetic Counseling Genetic counseling provides individuals with information about how genetic conditions may affect them or their families. Genetic counselors collect personal and family history and use such information to determine how likely it is that an individual or their family member has a genetic condition. Based on such information, a genetic counselor assists an individual in determining if a genetic test is suitable. Genetic test results can help diagnose, confirm, or indicate increased risk for developing a particular condition which genetic counseling can help explain the results and available treatment options. 13 Individuals may seek genetic counseling for multiple reasons, including: 14 10 Current law requires DOH to consult the National Practitioner Data Bank to verify whether adverse information is available for the registrant. 11 Florida law requires physicians, acupuncturists, chiropractic physicians, dentists, anesthesiologist assistants, advanced practice registered nurses, and licensed midwives to demonstrate $100,000 per claim and an annual aggregate of $300,000 of professional responsibility (see ss. 458.320 and 459.0085, F.S.; r. 64B1-12.001. F.A.C; r. 64B2-17.009, F.A.C.; 64B5-17.0105, F.A.C.; rr. 64B8- 31.006 and 64B15-7.006, F.A.C.; r. 64B9-4.002, F.A.C.; and r. 64B24-7.013, F.A.C.; respectively). Podiatric physicians must demonstrate professional responsibility in the amount of $100,000 (see r. 64B18-14.0072, F.A.C.). 12 These are professionals licensed under s. 393.17; part III, ch. 401; ch. 457; ch. 458; ch. 459; ch. 460; ch. 461; ch. 463; ch. 464; ch. 465; ch. 466; ch. 467; part I, part III, part IV, part V, part X, part XIII, and part XIV, ch. 468; ch. 478; ch. 480; part II and part III, ch. 483; ch. 484; ch. 486; ch. 490; or ch. 491. 13 Centers for Disease Control and Prevention, Genetic Counseling, https://www.cdc.gov/genomics/gtesting/genetic_counseling.htm (last visited January 13, 2023). 14 Id. Behavioral analyst Nurse Acupuncturist Pharmacist Allopathic physician Dentist Osteopathic physician Dental hygienist Chiropractor Midwife Podiatrist Speech therapist Occupational therapist Medical physicist Radiology technician Emergency Medical Technician Electrologist Paramedic Orthotist Massage therapist Pedorthist Optician Prosthetist Hearing aid specialist Clinical laboratory personnel Dietician/Nutritionist Respiratory therapist Athletic trainer Psychologist Clinical social worker Psychotherapist Marriage and family therapist Optometrist Mental health counselor STORAGE NAME: h0117c.HHS PAGE: 4 DATE: 3/17/2023 Addressing prenatal concerns about factors that might affect a baby during infancy, including genetic conditions and birth defects; Addressing concerns if a child is showing signs and symptoms of a genetic disorder, including abnormal newborn screening results, intellectual or developmental disabilities, or birth defects; Determining if an individual is at risk of being affected by a health condition, including hereditary breast and ovarian cancer, muscular dystrophy, Huntington’s disease, and sickle cell disease. Genetic counselors have advanced training in medical genetics and counseling to guide and support patients seeking more information about how inherited diseases and conditions might affect them or their families, and to interpret genetic test results based on personal and family history. Genetic counselors may specialize in prenatal, pediatric, oncology, neurology, ophthalmology, psychiatry, among many other areas. 15 Genetic counselors typically are not physicians; however, they work in conjunction with medical geneticists to provide genetic services. 16 Medical geneticists will order genetic testing and interpret the results and a genetic counselor will provide further education on the results and how they may affect an individual or their family. 17 The profession of genetic counseling is relatively new compared to other medical specialties. Scientific advancements over the last two decades have enabled genetic testing to become relatively accessible resulting in a rapid increase in the demand for professionals with specialized training in genetic counseling. 18 Nationally, the genetic counselor workforce grew by 88% between 2006 and 2016. 19 There are currently fewer than 5,500 certified genetic counselors practicing in the United States; this has led to frequent utilization of telehealth in order to provide services to address increasing demand, lack of access to providers, and health disparities. 20 Genetic counseling is unique in that evaluating a patient’s health and family history with genetic test results could be done almost entirely through telehealth services. Telehealth genetic counseling has been shown to be comparable in quality and outcomes to genetic counseling services rendered in-person. 21 Florida Genetic Counselors In 2021, the Legislature passed legislation creating part III of Chapter 483, F.S., related to the regulation of genetic counselors. 22 Current law authorizes genetic counselors to advise an individual or a family affected by or at risk of genetic disorders, including: 23 Evaluating individual and family medical histories to determine risk for genetic or medical conditions and diseases; Discussing health factors and risk management for genetic or medical conditions and diseases with patients; Ordering genetic laboratory tests and diagnostic studies; Evaluating laboratory test results and diagnostic studies against individual and family medical history to assess risk factors for genetic or medical conditions and diseases; Explaining clinical implications of genetic laboratory tests and diagnostic studies results to patients; Evaluating the individual or family and providing client centered counseling and guidance; 15 Id. 16 Medical geneticists are physicians who specialize in medical genetics and conduct genetic testing and provide diagnoses. 17 Supra, note 13. 18 Green, S., et al. (2022). An Evidence-based Practice Guideline of the National Society of Genetic Counselors for Telehealth Genetic Counseling. Journal of Genetic Counseling. 00, 1-14. https://doi.org/10.1002/jgc4.1627 19 American Board of Genetic Counseling, Inc. Workforce Study Executive Summary. Available at https://www.abgc.net/abgc/media/documents/Workforce_Study_Executive-Summary_FINAL.pdf (last visited February 7, 2023). 20 Id. 21 Danylchuk, N.R., et al. (2021). Telehealth for genetic counseling: A systematic evidence review. Journal of genetic counseling, 30(5), 1361–1378. https://doi.org/10.1002/jgc4.1481 22 S. 483.911, F.S. 23 S. 483.913(3), F.S. STORAGE NAME: h0117c.HHS PAGE: 5 DATE: 3/17/2023 Using community resources that provide medical, educational, financial, and psychosocial support and advocacy; Providing written documentation of medical, genetic, and counseling information for individuals, families, and health care professionals; and Referring individuals to a physician for diagnosis and treatment. To be licensed as a genetic counselor, an individual must meet the following requirements: 24 Has submitted an application on a form approved by DOH; Is of good moral character; Has earned a: o Master’s degree from a genetic counseling program or an equivalent program as determined by the Accreditation Council for Genetic Counseling or its successor or equivalent; or o Doctoral degree from a medical genetics program accredited by the American Board of Genetics and Genomics or the Canadian College of Medical Geneticists. Has passed the examination for certification as: o A genetic counselor by the American Board of Genetic Counseling, the American Board of Genetics and Genomics, or the Canadian Association of Genetic Counselors; or o A medical or clinical geneticist by the American Board of Medical Genetics and Genomics or the Canadian College of Medical Geneticists. There are currently 532 Florida-licensed genetic counselors, of which 107 (20%) live in-state and 425 (80%) live out-of-state. 25 Genetic counselors were not added to s. 456.74, F.S., list of health care practitioners authorized to provide services through telehealth. Genetic counselors are currently the only licensed health care practitioner type that cannot provide services through telehealth. There are 31 states regulating licensure for genetic counselors and all, except for Florida, authorize genetic counselors to provide services through telehealth. 26 Effect of the Bill The bill authorizes Florida licensed and out-of-state registered genetic counselors to provide services through telehealth. The bill provides an effective date of July 1, 2023. B. SECTION DIRECTORY: Section 1: Amends s. 456.47, F.S., relating to the use of telehealth to provide services. Section 2: Provides an effective date of July 1, 2023. II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT A. FISCAL IMPACT ON STATE GOVERNMENT: 24 S. 483.914, F.S. 25 Florida Department of Health. Division of Medical Quality Assurance. Annual Report and Long-Range Plan. Fiscal Year 2021-2022. Available at https://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/_documents/annual-report-2122.pdf (last visited February 6, 2023). 26 Florida Department of Health, Agency Analysis of 2023 House Bill 117, p. 2. On file with the Healthcare Regulation Subcommittee. STORAGE NAME: h0117c.HHS PAGE: 6 DATE: 3/17/2023 1. Revenues: None. 2. Expenditures: The bill has an indeterminate, insignificant negative fiscal impact on DOH which can be absorbed within current resources. 27 B. FISCAL IMPACT ON LOCAL GOVERNMENTS: 1. Revenues: None. 2. Expenditures: None. C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR: None. D. FISCAL COMMENTS: None. III. COMMENTS A. CONSTITUTIONAL ISSUES: 1. Applicability of Municipality/County Mandates Provision: Not applicable. The bill does not appear to affect county or municipal governments. 2. Other: None. B. RULE-MAKING AUTHORITY: DOH has sufficient rulemaking authority to implement the bill’s provisions. C. DRAFTING ISSUES OR OTHER COMMENTS: None. IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES 27 Supra note 26, at 5.